The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: Up to 90 days post last dose
The percentage of subjects with pathological Complete Response (pCR) after liver resection
Time frame: 3 years
The percentage of subjects with major pathological response (MPR) after liver resection
Time frame: 3 years
The percentage of subjects with R0 resection
Time frame: 3 years
Objective response rate (ORR) in two arms based on mRECIST by investigator
Time frame: 3 years
Disease-free survival (DFS) in two arms based on mRECIST by investigator
Time frame: 3 years
Overall survival (OS) in two arms
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.